Summary of California Green Chemistry by RSJ Technical Consulting

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What is California Green Chemistry?

California Health & Safety Code § 25251
California Code of Regulations § 69301 - Sept 2010

"California REACH" (composed of AB 1879 and SB 509) was signed into law September 2008 and is formally known as the Green Chemistry Initiative. The law establishes a framework for regulating toxic substances based upon "life cycle thinking and green chemistry principles."

The scope of the law is consumer products. Specifically excluded from the definition of consumer products are:
ê	Drugs and medical devices whose use requires a prescription (i.e. Rx only), medical devices other than contact lenses or prosthetics, dental materials used in tooth restoration other than dentures or implants, and packaging for the above products
ê	Human and animal foods, including drinks, confections, condiments and chewing gums
ê	Pesticides used to control any detrimental plant, animal, virus, fungus or bacteria
ê	Mercury-containing lights, bulbs, tubes or electrical devices used primarily for illumination -- but this exemption ends December 31, 2011

The Initiative is administered by the Department of Toxic Substances Control (DTSC) in the California Environmental Protection Agency. Draft regulations were issued for public comment in June 2010. Revised and much expanded "Proposed Regulations" were issued in September 2010 for legal review and scheduled to become effective January 1, 2011.

However, following the public comment period, a second set of "Proposed Regulations" were issued in November 2010 that were a substantive rewrite and simplification of the earlier text. Implementation has been delayed indefinitely while the Green Ribbon Science Panel is reconvened to address the programmatic issues that have been raised.

Summary of the "Proposed Regulations" as issued in September 2010:
The DTSC must prepare four prioritization lists. The first two lists are known collectively as Chemicals of Concern (COC). The first list, Chemicals Under Consideration List (CUC), is composed of all chemicals exhibiting a "hazard trait". The list of hazards casts a wide net that includes:
ê	Chemical and physical properties: 15 factors such as explosiveness, flash point, melting/boiling point, viscosity, water solubility
ê	Adverse public health impacts (including adverse impacts on sensitive subpopulations): 26 factors such as persistence, bioaccumulation, carcinogenicity, endocrine toxicity, musculoskeletal toxicity, neurotoxicity, reproductive toxicity, respiratory effects
ê	Adverse ecological impacts: 7 factors such as toxicity in aquatic/avian/ terrestrial organisms, adverse impacts on aquatic/teresstrial ecosystems, environmentally sensitive habitats, endangered species
ê	Adverse environmental impacts: 35 factors such as biodegradation, photodegradation, hydrolysis/aerobic/sediment half-lives, nitrogen/ sulfur oxides, greenhouse gases, organic aerosols, ozone-depleting compounds, oxygen demand in water, dissolved solids, priority pollutants, thermal pollution, soil erosion/compaction/contamination
ê	Dispersive volume: 6 factors such as sales by volume, regional distribution, mass of chemical used in products
ê	Potential for public or environmental exposure: 4 factors such as containment mechanisms, administrative controls, frequency and duration of exposure for each use scenario/end-of-life scenario
ê	The initial draft Chemicals under Consideration List is due June 2011; the final list is due March 2012.
The second list, Priority Chemicals List, identifies the CUC that pose the greatest threat to public health or the environment. The number of chemicals on this list will be limited by DTSC resources.
ê	Priority is given to chemicals that are widely used in consumer products and have the greatest potential for human or environmental exposure at harmful levels.
ê	Priority is given to chemicals causing harm to sensitive populations (such as children and pregnant women), environmentally sensitive habitats, and endangered/threatened species.
ê	The initial list is limited to chemicals that are carcinogens or reproductive toxins (listed by CA, EPA, WHO, or EU); mutagenic (listed by REACH); or persistent bioaccumulative toxic (listed by US EPA).
ê	The initial draft Priority Chemicals list is due July 2012.
Whenever a product containing a Chemical under Consideration or a Priority Chemical is reformulated, a Tier I Alternatives Assessment (AA) is required.
The last two lists prioritize products that contain a Priority Chemical. The third list, Products under Consideration List (PUC), identifies products likely to result in human/environmental exposure to the chemical. The list of factors includes:
ê	Dispersive volume: 7 factors such as annual sales, units in current use, percentage containing Priority Chemical
ê	Potential for public or environmental exposure: 4 factors such as containment mechanisms, administrative controls, frequency and duration of exposure for each use scenario/end-of-life scenario
ê	Types and extent of consumer use: 11 factors such as exposure in homes, schools, health care facilities, retail, business and service-sector locations
ê	Product uses or disposal practices: 6 factors such as use, storage, transportation, and end-of-life management, potential for release and accumulation
ê	The initial draft Products Under Consideration List is due March 2013.
The fourth list, Priority Products List, identifies the PUC that pose the greatest threat to public health or the environment. The number of chemicals on this list will be limited by DTSC resources.
ê	Priority is given to products that are widely used by consumers and have the greatest potential for human/environmental exposure to the Priority Chemical at harmful levels.
ê	Priority is given to products causing harm to sensitive populations (such as children and pregnant women), environmentally sensitive habitats, and endangered/threatened species.
ê	The initial draft Priority Products List is due Sept 2013; the final list is due Dec 2013.
When products are listed on the Priority Products List, each "responsible entity" incurs the following obligations:
ê	Priority Product Notification must be submitted within 60 days (provides contact information for manufacturer, importer, distributor, retailer and all persons involved in the supply chain).
ê	Tier II Alternatives Assessment (AA) must be initiated within 180 days and completed according to a schedule negotiated with the DTSC.
ê	Tier II AA must be performed by a Qualified Assessment Entity (may be third-party or in-house) approved by the DTSC. An accredited Lead Assessor must lead the assessment team.
ê	Tier II AA is not required if DTSC specifies a "de minimis" level based upon the lowest California or EPA regulatory threshold or 0.1% by weight (no nanomaterials); use a De Minimis Exemption Request instead.

The DTSC must issue a notice of proposed regulatory response within 60 days of receiving the completed Tier II AA. Following a public comment period, the Final Regulatory Response Determination is issued. DTSC regulatory options include:
ê	No regulatory response: The selected alternative replacing the Priority Chemical does not present a significant threat.
ê	Product information for consumers: Product must be labeled to identify the Priority Chemical, sensitive subpopulations that should avoid contact, safe handling information, and end-of-life disposal.
ê	End-of-life management: Product must be labeled for disposal as a hazardous waste. Within 2 years, manufacturer must establish, fund and maintain a product stewardship program for collecting/recycling the product at end-of-life as a cost of doing business.
ê	Product sales prohibition: Within 1 year of DTSC notification that a safer alternative exists (must be functionally equivalent, technologically and economically feasible), manufacturer must withdraw the product and recall inventory.
ê	Engineered safety measures: Product must be redesigned to control access/limit exposure to the Priority Chemical.
ê	Restrictions on use: Certain uses of the Priority Chemical are prohibited.
ê	Green chemistry R&D: Manufacturer is required to initiate a research and development project or fund a challenge grant.

Most of the chemical and product information submitted to DTSC will be posted on its website www.dtsc.ca.gov (trade secrets will be redacted). A partial listing includes:
ê	Petition to evaluate a chemical/product: anyone may submit to DTSC
ê	All responses received during public comment periods for the Chemicals under Consideration, Priority Chemicals, Products under Consideration, Priority Products Lists
ê	Exemption Determination: prepared by DTSC when manufacturer requests exemption for chemical/product because it is regulated by another regulatory agency or there is no exposure pathway
ê	Chemical Removal Notification (intent/confirmation): prepared by manufacturer when a Chemical under Consideration or a Priority Chemical is removed from the product
ê	Product Removal Notification (intent/confirmation): prepared by manufacturer when product containing a Chemical under Consideration or a Priority Chemical is withdrawn from stream of commerce
ê	Priority Product Notification: prepared by manufacturer when product is listed as a Priority Product
ê	AA Notification (Tier I): prepared by manufacturer when product containing a Priority Chemical is reformulated
ê	De Minimis Exemption Notice: prepared by DTSC when manufacturer requests exemption from Tier II AA because Priority Product contains minimal amounts of the Priority Chemical
ê	AA Work Plan (Tier II): prepared by manufacturer when product is listed as Priority Product
ê	AA Report (Tier II): prepared by manufacturer after AA is completed
ê	Regulatory Response Determination (proposed/final): prepared by DTSC after manufacturer has completed the Tier II AA
ê	All responses received during the public comment period for a proposed Regulatory Response
ê	Regulatory Response Exemption Request Determination: prepared by DTSC when manufacturer requests exemption because product is regulated by another regulatory agency or there is no exposure pathway
ê	Dispute Resolution Process: petition for review of DTSC regulatory response submitted by manufacturer; decision prepared by DTSC
ê	Product Stewardship Plan (hyperlink): prepared by manufacturer when end-of-life collection/recycling is required
ê	Audit Findings: prepared by DTSC after audit of any part of the program
ê	Failure to Comply List: prepared by DTSC when requested information is not received; list includes not only the manufacturer and importer, but also distributors, retailers and the entire supply chain

Note: the Green Ribbon Science Panel advises the DTSC on scientific matters, chemical policy recommendations and implementation strategies. Its twenty-seven members are experts in chemistry, materials science, nanotechnology, chemical engineering, pollution prevention, cleaner production methods, toxicology, risk analysis, public health, environmental law and public policy. Meeting at least twice yearly, the Panel ensures that DTSC implementation efforts are based on science.

This summary of the California Green Chemistry Initiative (GCI) is designed to provide you with an accurate, easy-to-understand overview of the topic. However:
ê	We have not attempted to cover the implementation issues that need to be addressed at your company or in your supply chain. For this type of assistance, please email or call us at 972-679-8996 to inquire about our services.
ê	This summary does not constitute legal advice. The actual standard in the original language should be reviewed and used for all business, legal, and product compliance purposes.

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